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FDA 510(k)

IMMUNOGLOBULIN G REAGENT SYSTEM

K-Number: K800119 · 1980-02-05

ApplicantCalbiochem-Behring Corp.
Decision Date1980-02-05
Product CodeDEW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNOGLOBULIN G REAGENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Calbiochem-Behring Corp.. It received FDA 510(k) clearance on 1980-02-05 under 510(k) number K800119. The device is classified under product code DEW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOGLOBULIN G REAGENT SYSTEM?

IMMUNOGLOBULIN G REAGENT SYSTEM is a medical device that received FDA 510(k) clearance on 1980-02-05. The listed applicant is Calbiochem-Behring Corp.. The 510(k) number is K800119.

When did IMMUNOGLOBULIN G REAGENT SYSTEM receive FDA 510(k) clearance?

IMMUNOGLOBULIN G REAGENT SYSTEM received FDA 510(k) clearance on 1980-02-05, under 510(k) number K800119.

Who is the listed applicant for IMMUNOGLOBULIN G REAGENT SYSTEM?

The FDA 510(k) record lists Calbiochem-Behring Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMUNOGLOBULIN G REAGENT SYSTEM?

The FDA product code for IMMUNOGLOBULIN G REAGENT SYSTEM is DEW.

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Other records listing Calbiochem-Behring Corp. as applicant

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Related Devices (Code: DEW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K050113TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K040434ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2Roche Diagnostics Corp.K010617SPIFE IFE CALIBRATOR AND CONTROL KITHelena LaboratoriesK993928WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARDWako Chemicals USA, Inc.K993281K-ASSAY IGGKamiya Biomedical Co.K983221IGGAbbott Laboratories

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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